GeriPal

JUNE 20, 2022

The All-Ukrainian Associate of Palliative and Hospice Care was founded in 2011 and is currently working to provide support and direct supplies to hospices and palliative care wards in the country. Families are unable to visit their loved ones and patients suffer from limited access to care and medications.

Supply Chain 55

Supply Chain Healthcare Professional Illness Healthcare 55

FDA Law Blog

JANUARY 22, 2024

Drug Supply Chain. Recalls, warning letters to online pharmacies, and drug-related import alerts were key tools for OC’s efforts to safeguard the drug supply chain from adulterated products over the prior fiscal year.

Supply Chain 59

Supply Chain Clinic IT Provider 59

FDA Law Blog

OCTOBER 12, 2022

Most states have some form of naloxone standing order that allows a healthcare provider to write a prescription that covers a large group of people rather than just an individual patient. Because naloxone is a prescription drug, its distribution is subject to the requirements of the Drug Supply Chain Security Act (DSCSA).

Supply Chain 52

Supply Chain Individual Provider Patient-Centered 52

The Medical Futurist

MAY 18, 2025

A human-sized, smiling robot combines the very best in cutting-edge technology and human touch to provide frequent check-ins and non-medical care for residents in long-term care settings. And we could go on and on with the examples of social robots involved in elderly care. Exoskeletons started finding their place in healthcare systems.

Healthcare 64

Healthcare Hospital Medical Patient-Centered 64

FDA Law Blog

AUGUST 27, 2023

FDA states this will “facilitate the use and exhaustion of product supply already in the supply chain prior to November 27, 2024.” As industry is well aware, by the terms of the statute, the DSCSA’s interoperability provisions become effective ten years after its 2013 enactment, or on November 27, 2023. Guidance at 5.

Supply Chain 52

Supply Chain Electronics Manufacturing Provider 52

FDA Law Blog

SEPTEMBER 16, 2024

“Innovative manufacturing” is a somewhat ill-defined term, but the agency uses it to refer to any novel manufacturing that can increase product development speed, bolster supply chains, or prevent drug shortages. Regarding CBER’s CATT, the center is currently revising its internal procedures, referred to as CATT 2.0,

Manufacturing 59

Manufacturing IT Supply Chain Provider 59

FDA Law Blog

FEBRUARY 4, 2022

Richardson — FDA has released its Proposed Rule of National Standards for Third-Party Logistics Providers (“3PLs”) and Prescription Drug Wholesale Distributors (“WDDs”). The Rule, if enacted in its current form, will have sweeping implications throughout the supply chain, but particularly for WDDs and 3PLs. By Karla L.

Supply Chain 40

Supply Chain Manufacturing Provider IT 40

FDA Law Blog

JULY 18, 2023

The report reiterated a commitment to maintain the supply chain and provides more context about how OPQ—and FDA, more generally—are approaching quality and enforcement as we continue to hurtle past the COVID-19 public health emergency (PHE).

Supply Chain 52

Supply Chain Manufacturing IT Provider 52

FDA Law Blog

FEBRUARY 26, 2025

How will the imposition of tariffs and a burgeoning trade war affect domestic drug production and companies supply chain demands? Good habits that include effective, thoughtful communications provide clarity, understanding, and by hopefully avoiding crises, profitability. HPM Counsel John W.M.

Supply Chain 66

Supply Chain Management IT Manufacturing 66

FDA Law Blog

MARCH 1, 2023

In this report, it’s stated that 62% of drug shortages reported between 2012 and 2017 were due to quality issues which is attributed in part to a lack of recognition or reward for manufacturers with mature quality management systems that focus on continuous improvement and early detection of supply chain issues.

Management 45

Management Manufacturing Supply Chain Provider 45

FDA Law Blog

MARCH 4, 2024

The draft guidance provides recommendations for applicants and manufacturers about the requirements for notifications about production changes of certain finished drugs and biological products and certain active pharmaceutical ingredients (API), and outlines information FDA would like to receive in addition to the requirements.

Manufacturing 59

Manufacturing Supply Chain Provider Treatment Plan 59

FDA Law Blog

JUNE 3, 2021

Schlanger — While federal efforts to address prescription drug prices are debated, states have continued to pursue their own measures that require drug manufacturers and other entities in the drug supply chain to disclose information about pricing. See our previous coverage of such state laws here , here and here.)

Manufacturing 52

Manufacturing Supply Chain Insurance Provider 52

FDA Law Blog

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. Finally, as a general matter, every firm needs to make sure its supply chain stakeholders (e.g.,

Specialization 45

Specialization Supply Chain Manufacturing Medical 45

FDA Law Blog

DECEMBER 8, 2021

Moore — Nothing says “happy holidays” quite like the issuance of Federal Trade Commission (FTC) orders – essentially, subpoenas – to large retailers , wholesalers and suppliers of food, cosmetics, personal care and OTC products, among other things, during the supply chain’s busiest time of the year. Amazon.com, Inc., Kroger Co.,

Supply Chain 52

Supply Chain Transportation IT Provider 52

FDA Law Blog

APRIL 8, 2024

Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response.

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

FDA Law Blog

NOVEMBER 22, 2022

But as noted above, identifying points in the food supply chain, the source of the product, and where contamination may have occurred can be a long and difficult process. What information firms must maintain and share under the rule depends on the type of activities they perform in the supply chain with respect to an FTL food.

Supply Chain 52

Supply Chain Illness Family Families 52

FDA Law Blog

OCTOBER 11, 2023

In general, both of these guidances provide recommendations for sponsors to consider and analyze when a disaster (e.g., For example, a disaster or public health emergency may lead to clinical trial disruptions via population quarantines, travel restrictions, various interruptions to the supply chain, and other logistical issues.

Clinic 64

Clinic Supply Chain Clinical Practice Patient-Centered 64

FDA Law Blog

FEBRUARY 16, 2023

sales of naloxone from a wholesale distributor to a harm reduction program) from certain requirements under the Drug Supply Chain Security Act. We previously blogged on FDA’s September 2022 guidance exempting and excluding specific naloxone transactions (e.g.,

Supply Chain 64

Supply Chain Healthcare Professional Community IT 64

FDA Law Blog

JANUARY 24, 2024

Karst — In September 2022, while the world was still in the midst of the COVID-19 epidemic and dealing with significant supply chain woes, President Biden issued an Executive Order— Executive Order 14081 —titled “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.”

Supply Chain 69

Supply Chain Manufacturing Government Provider 69

BMJ

AUGUST 20, 2021

In the United Kingdom (UK), primary care practitioners are the first-line clinicians which most patients encounter, providing initial assessment and treatment of a wide variety of conditions. Over one billion prescriptions per year are signed in the UK by these general practitioners (GPs) in primary care.

Primary Care 40

Primary Care Supply Chain General Practitioner Vaccination 40

GeriPal

SEPTEMBER 14, 2023

And we would provide ongoing longitudinal care to them in the home, much like the Mount Sinai Visiting Doctors programs, and other programs like that. And the treatments are different than what hospice might provide in the home setting. I trained at Hopkins. We had, since the late seventies, a home-based primary care program.

Hospital 115

Hospital Patient-Centered Supply Chain IT 115

FDA Law Blog

JANUARY 9, 2024

This request must provide details about, among other things: The foreign seller that will purchase the prescription drug directly from its manufacturer, along with invoices, batch, and lot/control numbers to verify the sale and the units sold. See 21 C.F.R. 251.5; § 251.6(c).

Supply Chain 59

Supply Chain Manufacturing Chronic Condition Government 59

FDA Law Blog

SEPTEMBER 13, 2021

Pharmacopeia (“USP”) monograph standards; providing greater flexibility and clarity regarding the inclusion of data from animal studies; and incentivizing second-in-market brands to increase competition between brand drugs. Increase Transparency and Strengthen Supply Chain and Research Capacity. ADMINISTRATIVE ACTIONS.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98